ICH GCP
FDA
MHRA
JSQA
CRO List
Clinical Trials
Clinical Research Jobs
2020 Coronavirus Outbreak
ICH GCP
FDA
MHRA
JSQA
CRO List
Clinical Trials
Clinical Research Jobs
2020 Coronavirus Outbreak
ICH GCP | Clinical Trials Registry
A Phase III Clinical Trial Evaluating DCVax®-L, Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen For The Treatment Of Glioblastoma Multiforme (GBM)
Study of a Drug [DCVax®-L] to Treat Newly Diagnosed GBM Brain Cancer
Sponsors
Lead Sponsor
Northwest Biotherapeutics
Source
Northwest Biotherapeutics
Oversight Info
Has Dmc
Yes
Brief Summary
The primary purpose of the study is to determine the efficacy of an investigational therapy called DCVax(R)-L in patients with newly diagnosed GBM for whom surgery is indicated. Patients must enter screening at a participating site prior to surgical resection of the tumor. Patients will receive the standard of care, including radiation and Temodar therapy and two out of three will additionally receive DCVax-L, with the remaining one third receiving a placebo. Patients randomized to the placebo arm will have the option to receive DCVax-L in a crossover arm upon documented disease progression. (note: DCVax-L when used for patients with brain cancer is sometimes also referred to as DCVax-Brain)
Detailed Description
This Phase III trial is designed to evaluate the impact on disease progression and survival time, as well as safety, in patients following treatment with DCVax(R)-L, an immunotherapy treatment for GBM. The experimental therapy uses a patient's own tumor lysate and white blood cells from which precursors of the dendritic cells are isolated. The dendritic cell is the starter engine of the immune system. The white cells are then made into dendritic cells and they are educated to "teach" the immune system how to recognize brain cancer cells. Eligible patients will receive a series of injections of DCVax-L, to activate and then boost the immune response to the tumor cells. The primary study endpoint is PFS (progression free survival), and the first secondary endpoint is overall survival (OS). Other endpoints include performance status, immune response, and also safety. Interim analyses to assess efficacy are incorporated in the trial design. Side effects reported from early trials are mostly mild, and may include skin reactions of redness, pain & swelling at the injection site.
Overall Status
Unknown status
Start Date
2006-12-01
Completion Date
N/A
Primary Completion Date
2016-11-01
Phase
Phase 3
Study Type
Interventional
Primary Outcome
Measure
Time Frame
The primary objective of this study is to compare progression free survival from time of randomization between patients treated with DCVax-L and control patients.
Time to tumor progression or death
Secondary Outcome
Measure
Time Frame
The secondary objective is to compare overall survival and time to disease progression between DCVax-L treated and control patients.
Until Death
Enrollment
348
Conditions
Glioblastoma Multiforme , Glioblastoma , GBM , Grade IV Astrocytoma , Glioma , Brain Cancer , Brain Tumor
Intervention
Intervention Type
Drug
Intervention Name
Dendritic cell immunotherapy
Description
Two intradermal (i.d.) injections of DCVax-L(treatment cohort) or autologous PBMC (placebo cohort) per treatment. Treatments will be given at days 0, 10, 20, and at weeks 8, 16, 32, 48, 72, 96 and 120.
Arm Group Label
Placebo Chohort
treatment cohort
Other Name
DCVax-L
DCVax
DCVax-Brain
Eligibility
Criteria
Inclusion Criteria: All patients must meet the following inclusion criteria. All tests and eligibility criteria must be completed within four weeks of completion of radiation and chemotherapy, following surgery. - Patients must have sufficient tumor lysate protein that was generated from the surgically obtained tumor material. Patients must also have sufficient DCVax-L product available after manufacturing. These determinations will be made by Cognate BioServices, Inc. (Cognate) and communicated to the clinical site through the Sponsor, or its designee. - Patients with newly diagnosed, unilateral GBM (Grade IV) are eligible for this protocol. An independent neuropathologist will review this diagnosis during the enrollment process. - Subjects ≥18 and ≤70 years of age at surgery who are capable of informed consent. Patients must be able to understand and sign the informed consent documents indicating that they are aware of the investigational nature of this study. - Patients must have a life expectancy of >8 weeks. - Patients must have a KPS rating of ≥70 at the baseline visit (Visit 3). - Primary therapy must consist of surgical resection with the intent for a gross or near total resection of the contrast-enhancing tumor mass, followed by conventional external beam radiation therapy and concurrent Temodar chemotherapy. Patients having a biopsy only will be excluded. These primary treatments must be completed at least two weeks prior to first immunization. - Patients may have received steroid therapy as part of their primary treatment. Steroid treatment must be stopped at least 10 days prior to leukapheresis. - Patients must not have progressive disease at completion of radiation therapy. Patients with suspected pseudoprogression will be enrolled and analyzed separately. - Patients must be willing to forego cytotoxic anti-tumor therapies except temozolomide essentially according to the schedule of the Stupp Protocol (Stupp et al. N Engl J Med 352: 987-96, 2005) while being treated with DCVax-L. DCVax-L treatment must be given as described and temozolomide/Temodar treatment schedules must be given essentially according to the Stupp Protocol. - Patients must have adequate bone marrow function (e.g., hemoglobin >10 g/dl, white blood count 3600-11,000mm3, absolute granulocyte count ≥1,500/mm3, absolute lymphocyte count ≥1,000/mm3, and platelet count ≥100K/mm3. Eligibility level of hemoglobin can be reached by transfusion. - Adequate liver function (SGPT, SGOT, and alkaline phosphatase ≤1.5 times upper limits of normals (ULN) and total bilirubin ≤1.5mg/dl), and adequate renal function (BUN or creatinine ≤1.5 times ULN) prior to starting therapy.
Gender
All
Minimum Age
18 Years
Maximum Age
70 Years
Healthy Volunteers
No
Overall Official
Last Name
Role
Affiliation
Linda Liau, M.D.
Principal Investigator
University of California, Los Angeles
Marnix L. Bosch, MBA, PhD
Study Director
Northwest Biotherapeutics
Location
Facility
University of Alabama at Birmingham
Birmingham Alabama 35294 United States
University of Arkansas for Medical Sciences
Little Rock Arkansas 72205 United States
Sutter East Bay Neuroscience Institute-Eden Medical Center
Castro Valley California 94546 United States
City of Hope
Duarte California 91010 United States
UCSD Moores Cancer Center
La Jolla California 93093 United States
Kaiser Permanente - Los Angeles
Los Angeles California 90027 United States
UCLA Medical Center
Los Angeles California 90095 United States
Hoag Memorial Hospital Presbyterian
Newport Beach California 92663 United States
St. Joseph Hospital of Orange
Orange California 92868 United States
University of California, Irvine Medical Center
Orange California 92868 United States
Kaiser Permanente - Redwood City
Redwood City California 94063 United States
Sutter Institute for Medical Research
Sacramento California 95816 United States
University of Colorado Cancer Center
Aurora Colorado 80045 United States
Colorado Neurological Institute
Englewood Colorado 80113 United States
Georgetown University Medical Center
Washington District of Columbia 20057 United States
University of Florida
Gainesville Florida 32611 United States
Memorial Cancer Institute
Hollywood Florida 33021 United States
Mount Sinai Community Clinical Oncology Program
Miami Beach Florida 33140 United States
Moffitt Cancer Center
Tampa Florida 33612 United States
Piedmont Atlanta Hospital
Atlanta Georgia 30309 United States
Rush University Medical Center
Chicago Illinois 60612 United States
Illinois Cancer Care
Peoria Illinois 61615 United States
Cadence Cancer Center
Warrenville Illinois 60555 United States
IU Simon Cancer Center
Indianapolis Indiana 46202 United States
University of Kansas Cancer Center
Westwood Kansas 66205 United States
Markey Cancer Center/University of Kentucky
Lexington Kentucky 40536 United States
Norton Cancer Institute
Louisville Kentucky 40202 United States
Tufts Medical Center
Boston Massachusetts 02111 United States
Beth Israel Deaconess Medical Center
Boston Massachusetts 02215 United States
University of Michigan Cancer Center
Ann Arbor Michigan 48109 United States
Henry Ford Hospital
Detroit Michigan 48202 United States
Spectrum Health
Grand Rapids Michigan 49503 United States
John Nasseff Neuroscience Institute at Abbott Northwestern Hospital
Minneapolis Minnesota 55407 United States
St. Luke's Hospital
Kansas City Missouri 64111 United States
Washington University School of Medicine
St. Louis Missouri 63110 United States
The Brain Tumor Center at JFK Medical Center
Edison New Jersey 08818 United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack New Jersey 07601 United States
The Valley Hospital
Ridgewood New Jersey 07450 United States
Overlook Hospital
Summit New Jersey 07902 United States
Capital Health Regional Medical Center
Trenton New Jersey 08638 United States
Long Island Brain Tumor Center at Neurological Surgery, P.C.
Lake Success New York 11042 United States
North Shore University Hospital
Manhasset New York 11030 United States
New York University Clinical Cancer Center
New York New York 10016 United States
Mount Sinai Medical Center
New York New York 10029-6574 United States
Columbia University Medical Center
New York New York 10032 United States
University of Rochester Medical Center
Rochester New York 14642 United States
Stony Brook Medicine
Stony Brook New York 11794 United States
Brain and Spine Surgeons of New York and Northern Westchester Hospital
White Plains New York 10604 United States
University of North Carolina, Chapel Hill
Chapel Hill North Carolina 27514 United States
Wake Forest Baptist Medical Center
Winston-Salem North Carolina 27157 United States
University of Cincinnati Cancer Institute
Cincinnati Ohio 45267 United States
University Hospitals Seidman Cancer Center
Cleveland Ohio 44106 United States
Cleveland Clinic Foundation
Cleveland Ohio 44195 United States
Ohio State University
Columbus Ohio 43210 United States
OhioHealth
Columbus Ohio 43214 United States
Oklahoma University Health Science Center
Oklahoma City Oklahoma 73104 United States
Geisinger Medical Center
Danville Pennsylvania 17822 United States
Hospital of the University of Pennsylvania
Philadelphia Pennsylvania 19104 United States
Jefferson Hospital for Neuroscience
Philadelphia Pennsylvania 19107 United States
Temple University School of Medicine
Philadelphia Pennsylvania 19140 United States
Rhode Island Hospital
Providence Rhode Island 02903 United States
Medical University of South Carolina Hospitals and Clinics
Charleston South Carolina 29425 United States
Saint Thomas Research Institute
Nashville Tennessee 37205 United States
Vanderbilt Ingram Cancer Center
Nashville Tennessee 37232 United States
Baylor Research Institute
Dallas Texas 75246 United States
The Methodist Hospital
Houston Texas 77030 United States
University of Texas Health Science Center at Houston
Houston Texas 77030 United States
Cancer Therapy & Research at University of Texas Health Science Center San Antonio
San Antonio Texas 78229 United States
Benaroya Research Institute at Virginia Mason
Seattle Washington 98101 United States
Swedish Hospital Neuroscience Research
Seattle Washington 98122 United States
Aurora Saint Luke's Medical Center
Milwaukee Wisconsin 23215 United States
Montreal Neurological Institute, McGill University
Montreal Quebec H3A 2B4 Canada
CHUS - Hôpital Fleurimont
Sherbrooke Quebec J1H 5N4 Canada
Universitätsklinikum Heidelberg Neurochirurgische Klinik
Heidelberg Baden-Württemberg 69120 Germany
Katharinenhospital
Stuttgart Baden-Württemberg 70174 Germany
Universitätsklinikum FrankfurtKlinik und Poliklinik für Neurochirurgie
Frankfurt Hesse 60528 Germany
Universitätsklinikum Bonn Nervenklinik (Zentrum), Klinik und Poliklinik für Neurochirurgie
Bonn North Rhine-Westphalia 53105 Germany
Universitätsklinikum Klinik für allgemeine Neurochirurgie
Köln North Rhine-Westphalia 50924 Germany
BG-Kliniken Bergmannstrost, Klinik für Neurochirurgie
Halle Saxony-Anhalt 06112 Germany
Klinik für Neurochirurgie, Klinikum Chemnitz gGmbH
Chemnitz Saxony 09116 Germany
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dresden Saxony 01307 Germany
Neurochirurgische Klinik
Hamburg 20246 Germany
Addenbrookes NHS Trust
Cambridge Cambridgeshire, East Anglia CB2 2QQ United Kingdom
Kings College Hosital NHS Foundation Trust
London Greater London SE5 9RS United Kingdom
University College Hospital London
London Greater London WC1E 6BT United Kingdom
University Hospital of Birmingham NHS Foundation Trust
Birmingham West Midlands N15 2WB United Kingdom
Location Countries
Country
Canada
Germany
United Kingdom
United States
Verification Date
2016-10-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
oncology , neurology , glioma , brain tumor , brain cancer , glioblastoma multiforme , glioblastoma , newly diagnosed glioblastoma , immunotherapy , dendritic cells , immune therapy , GBM , Brain cancer, primary , tumor vaccine , grade IV astrocytoma , DCVax , Grade IV brain cancer
Has Expanded Access
No
Condition Browse
Glioblastoma , Glioma , Brain Neoplasms , Astrocytoma
Number Of Arms
2
Arm Group
Arm Group Label
treatment cohort
Arm Group Type
Active Comparator
Arm Group Label
Placebo Chohort
Arm Group Type
Placebo Comparator
Description
Autologous PBMC
Firstreceived Results Date
N/A
Acronym
GBM
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Study First Submitted
September 17, 2002
Study First Submitted Qc
September 18, 2002
Study First Posted
September 19, 2002
Last Update Submitted
October 12, 2016
Last Update Submitted Qc
October 12, 2016
Last Update Posted
October 14, 2016
Last Known Status
Active, not recruiting
ClinicalTrials.gov processed this data on May 22, 2020
Recent Jobs
Medical Technologist II (1st shift)
Indianapolis, Indiana, United States
CRA I/ II - sponsor dedicated
Budapest, Hungary
Proposal Associate
Madison, Wisconsin, United States
Principle Investigator/Lead Scientist II-Immunochemistry
Somerset, New Jersey, United States
Clinical Research Manager (6 months FTC)
Lisbon, Portugal
Clinical research organizations
Cmed
Innovative Clinical Concepts (ICC)
Navitas Life Sciences
BioRASI Clinical Research
MTZ Clinical Research
Conditions
Alphabetic (A-Z)
By Category
Rare Diseases
Alphabetic (A-Z)
Drug
Interventions
Alphabetic (A-Z)
By Category
Dietary
Supplements
Alphabetic (A-Z)
By Category
Sponsor/
Collaborators
Alphabetic (A-Z)
By Category
Locations
Alphabetic (A-Z)
By Category
AI
